Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
Completed
Conditions studied: Breast Cancer
In brief
The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.
Key facts
- Study ID
- NCT00802932
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 61
- Starts
- 2008-03-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2013-01-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer
- Any invasive adenocarcinoma or intraductal carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Surgical treatment with lumpectomy (partial mastectomy)
- Successful placement of intraparenchymal metallic markers at last breast surgery
- Pathologic tumor size < 5.0 cm (Microscopic multifocality is allowed if total pathologic tumor size is within 5 cm)
- Axillary sampling (sentinel node or axillary dissection) performed for axillary nodal staging for all invasive cancers. No axillary sampling is required for ductal carcinoma in situ)
- Negative margins of excision.
- Radiation treatment to begin within 8 weeks after last surgery or last dose of chemotherapy
- Negative post-biopsy mammogram if presented with mammographically detected microcalcifications to ensure removal of suspicious calcifications
- History of prior cancers is allowed if patient is without evidence of disease at the time of study entry
- Ability to understand and the willingness to sign written informed consent document
You may not qualify if…
- Pregnant or breast feeding at time of study entry. Note: Radiation therapy is teratogenic. Women of child bearing potential must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to and during study participation. Should a woman become pregnant, she should inform the treating physicians immediately.
- Prior in-field irradiation
- Stage III or IV breast cancer
- Inability to place intraparenchymal metallic markers due to excessive bleeding or other intraoperative complication so that the surgeon deems it inadvisable to place the marker
- Pathologic tumor size >/= 5 cm
- Positive or unassessed margins of surgical resection
- Diffuse calcifications on mammogram pre- or post-operatively
- Positive or suspicious post-lumpectomy mammogram or breast magnetic resonance imaging (MRI)
- Multicentric carcinoma in more than one quadrant of the breast
- Non-epithelial breast malignancy; Paget's disease of the nipple
- Personal history of collagen vascular disease clinically judged to be a contraindication to radiation therapy
- Recurrent disease or prior history of ipsilateral breast cancer
- Psychiatric or addictive disorders that impair patient's voluntary ability to participate in informed consent or protocol procedures
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute, Inc. — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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